@article{143686b66e1d439fbcaf8e49015580b7,
title = "Treatment and relapse of interstitial lung disease in nivolumab-treated patients with non–small cell lung cancer",
abstract = "Nivolumab, a human monoclonal antibody against programmed death-1, is approved for the treatment of non–small cell lung cancer (NSCLC). Although nivolumab is generally well tolerated, it can cause interstitial lung disease (ILD), a rare but potentially fatal immune-related adverse event. Currently, there are limited data available on the treatment of nivolumab-induced ILD and its outcome. This retrospective cohort study based on a post–marketing study described the treatment of nivolumab-induced ILD and its outcome in NSCLC patients in Japan through the assessment of clinical and chest imaging findings by an expert central review committee. Treatment details for patients who experienced a relapse of ILD were also analyzed. Of the 238 patients identified as having nivolumab-induced ILD, 37 patients died of ILD. Corticosteroids were used in 207 (87.0%) patients. Of those, 172 (83.1%) patients responded well and survived and 35 (16.9%) died (most died during corticosteroid treatment). A total of nine patients experienced a relapse; at the time of relapse, four patients were taking nivolumab. Of those who were receiving corticosteroids at the time of relapse, three of four patients were taking low doses or had nearly completed dose tapering. All patients (except one, whose treatment was unknown) received corticosteroids for the treatment of relapse, but one patient died. Patients with NSCLC who experience nivolumab-induced ILD are treated effectively with corticosteroids, and providing extra care when ceasing or reducing the corticosteroid dose may prevent relapse of ILD.",
keywords = "Adverse drug events, Immunotherapy, Interstitial lung disease, Nivolumab, Non-small-cell lung carcinoma",
author = "Masafumi Sata and Shinichi Sasaki and Katsunori Oikado and Yoshinobu Saito and Junya Tominaga and Fumikazu Sakai and Terufumi Kato and Tae Iwasawa and Hirotsugu Kenmotsu and Masahiko Kusumoto and Tomohisa Baba and Masahiro Endo and Yutaka Fujiwara and Hiroaki Sugiura and Noriyo Yanagawa and Yoshihiko Ito and Takahiko Sakamoto and Yuichiro Ohe and Kazuyoshi Kuwano",
note = "Funding Information: The authors would like to thank all study participants. This study was supported by Ono Pharmaceutical Co., Ltd. and Bristol‐Myers Squibb K.K. Medical writing assistance was provided by Rebecca Lew, PhD, CMPP, and Hana Nomura, BPharm (Hons), of ProScribe—Envision Pharma Group, and was funded by Ono Pharmaceutical Co., Ltd. ProScribe{\textquoteright}s services complied with international guidelines for Good Publication Practice (GPP3). Data management services were provided by Rie Hori of Micron and were funded by Ono Pharmaceutical Co., Ltd. and Bristol‐Myers Squibb K.K. Funding Information: Y. Saito reports personal fees from AstraZeneca and Ono. K. Oikado reports personal fees from Konica Minolta Precision Medicine Japan, Ono, and Takeda. J. Tominaga, N. Yanagawa, and K. Kuwano report personal fees and/or grants from Ono. M. Sata and F. Sakai report personal fees from AstraZeneca and Ono. T. Kato reports personal fees and/or grants from AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Daiichi‐Sankyo, Eli Lilly, Merck Biopharma, MSD, Nippon Kayaku, Novartis, Ono, Pfizer, Regeneron, Shionogi, Taiho, and Takeda. H. Kenmotsu reports personal fees and/or grants from AstraZeneca, Chugai, and Ono. M. Kusumoto reports personal fees from AstraZeneca, Canon Medical Systems, MSD, and Ono. T. Baba reports personal fees from AstraZeneca, BMS, and Ono. Y. Fujiwara reports grants from AbbVie, Eisai, Eli Lilly, Incyte, and Merck Serono, grants and personal fees from AstraZeneca, BMS, Chugai, Daiichi‐Sankyo, MSD, and Novartis, and personal fees from Ono, outside the submitted work. Y. Ito and T. Sakamoto are employed by Ono. Y. Ohe reports personal fees and/or grants from AstraZeneca, BMS, Chugai, MSD, and Ono. M. Endo, T. Iwasawa, S. Sasaki, and H. Sugiura have no conflicts of interest to declare. Funding Information: The authors would like to thank all study participants. This study was supported by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. Medical writing assistance was provided by Rebecca Lew, PhD, CMPP, and Hana Nomura, BPharm (Hons), of ProScribe?Envision Pharma Group, and was funded by Ono Pharmaceutical Co., Ltd. ProScribe?s services complied with international guidelines for Good Publication Practice (GPP3). Data management services were provided by Rie Hori of Micron and were funded by Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. Publisher Copyright: {\textcopyright} 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.",
year = "2021",
month = apr,
doi = "10.1111/cas.14715",
language = "English",
volume = "112",
pages = "1506--1513",
journal = "Cancer Science",
issn = "1347-9032",
publisher = "Wiley-Blackwell",
number = "4",
}